(271 days)
Not Found
No
The summary describes a remote control module for an existing energy platform, focusing on integration and control of existing functions via a touch screen interface. There is no mention of AI, ML, or any features that would typically involve such technologies. The performance studies focus on software verification and validation of interfaces and functional requirements, not on the performance of an AI/ML algorithm.
No
The device is a control module for an energy platform, designed to control the platform remotely within an integrated surgical suite, rather than directly providing therapy to a patient.
No
Explanation: The device is described as a control module for an energy platform used in a surgical suite. Its function is to enable remote control of the ForceTriad unit, not to diagnose medical conditions or interpret medical data.
No
The device is described as an "additional function" to an "integrated operating room system" which controls various hardware components (video displays, cameras, audio video equipment). While the "Control Module" itself might be software, it is explicitly integrated into a larger system that includes hardware, and its function is to control a hardware device (ForceTriad Energy Platform). The description does not indicate it is a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to control the Covidien ForceTriad Energy Platform remotely within an integrated surgical suite. This is a surgical control device, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description reinforces that it's a control module for surgical equipment and video/audio routing in an operating room.
- No mention of analyzing biological samples: There is no indication that this device interacts with or analyzes any biological samples (blood, tissue, urine, etc.).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device's function is entirely related to controlling surgical equipment and managing information flow within an operating room.
N/A
Intended Use / Indications for Use
The IDSS-ForceTriad Control Module is designed for integration in the IDSS (Integrated Digital Surgical Suite) and enables the Covidien ForceTriad Energy Platform to be controlled remotely.
Product codes
ODA
Device Description
The IDSS ForceTriad Control Module is an additional function to the IDSS, which is an integrated operating room system controlling video displays, observation cameras, audio video equipment, teleconferencing and the routing of video and images from multiple sources to multiple destinations via a touch screen interface. With the IDSS ForceTriad Control Module, operation room staff is able to control the ForceTriad setup from the touch panel location rather than using the ForceTriad unit itself.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operation room staff / integrated operating room system
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Software Verification and Validation testing were performed on interfaces, feature functional requirements, and non-functional reliability. The software validation activities were performed in accordance with the FDA Guidance “Guidance for the content of premarket Submissions for Software Contained in Medical Devices”. The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing right, arranged in a cascading manner. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top and left side of the profile graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2016
Black Diamond Video, Inc. Mr. Ragunath Muniandy Regulatory Affairs Specialist 503 Canal Blvd Richmond, California 94804
Re: K153205
Trade/Device Name: IDSS ForceTriad Control Module Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODA Dated: June 27, 2016 Received: June 30, 2016
Dear Mr. Muniandy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Christopher J. Ronk -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153205
Device Name IDSS –ForceTriad Control Module
Indications for Use (Describe)
The IDSS-ForceTriad Control Module is designed for integration in the IDSS(Integrated Digital Surgical Suite) and enables the Covidien ForceTriad Energy Platform to be controlled remotely.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Black Diamond Video, which includes a stylized diamond shape on the left and the letters "BDV" in bold, black font on the right. The diamond shape is made up of smaller diamonds, with a blue diamond in the center. Below the letters "BDV" is the text "BLACK DIAMOND VIDEO" in a smaller, light blue font. The logo has a modern and professional look.
510(K) Summary
Date Prepared: 10/15/2015
| 510K Owner: | Black Diamond Video
503 Canal Blvd
Richmond, CA94804 |
|-------------|------------------------------------------------------------|
| Contact: | Ragunath Muniandy, RAC
Regulatory Affairs Specialist |
| Trade Name: | IDSS -ForceTriad Control Module |
|---|---|
| Common Name: | Endoscope and accessories |
| Classification Name: | Endoscopic central control unit |
| Classification Panel: | Gastroenterelogy/Urology |
| CFR section: | 21 CFR 876.1500 |
| Class: | 2 |
| Product Code: | ODA |
| Predicate Device : | Karl Storz SCB/Covidien ForceTriad Interface Module |
| (K111165) | |
| Device Description: | The IDSS ForceTriad Control Module is an additional function |
| to the IDSS, which is an integrated operating room system | |
| controlling video displays, observation cameras, audio video | |
| equipment, teleconferencing and the routing of video and | |
| images from multiple sources to multiple destinations via a | |
| touch screen interface. With the IDSS ForceTriad Control | |
| Module, operation room staff is able to control the ForceTriad | |
| setup from the touch panel location rather than using the | |
| ForceTriad unit itself. |
4
Image /page/4/Picture/0 description: The image shows the logo for Black Diamond Video (BDV). The logo features a stylized diamond shape on the left, with the letters "BDV" in bold, sans-serif font to the right. Below the letters, the words "BLACK DIAMOND VIDEO" are written in a smaller font. The diamond shape is made up of smaller diamonds, with a blue diamond in the center.
Indications for use: The IDSS-ForceTriad Control Module is designed for integration in the IDSS (Integrated Digital Surgical Suite) and enables the Covidien ForceTriad Energy Platform to be controlled remotely..
Substantial Equivalence
| (SE) Rational: | The IDSS –ForceTriad Control Module is substantially
equivalent to the predicate device since intended use,
operational principle, basic technology and design are similar.
The minor differences between the IDSS –ForceTriad Control
Module and the predicate device raise no new issues of safety
and effectiveness, as these differences have no effect on the
performance, function or general intended of use of the device.
Therefore based on the applicable testing and the equivalence
information presented in this submission, Black Diamond
Video believes that IDSS –ForceTriad Control Module does
not raise any new safety or efficacy issues. |
| ---------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Summary of Nonclinical
| Testing: | - Software Verification and Validation testing were performed
on interfaces, feature functional requirements, and non-
functional reliability. The software validation activities were
performed in accordance with the FDA Guidance “Guidance
for the content of premarket Submissions for Software
Contained in Medical Devices”. The risk analysis was carried
out in accordance with established in-house acceptance criteria
based on ISO 14971:2007. |
| ---------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- Conclusion: Testing and evaluation indicate that the system meets the needs of the users of the device and does not raise any new safety and efficacy of the predicate device.